Kornimate/medical-research-clean huggingface dataset:
management of bleeding following cardiopulmonary bypass

Conditions: Hemorrhage; Cardiopulmonary Bypass

Summary: we believe ongoing bleeding during complex cardiac surgery can be accurately measured and that administration of a specific blood product replacement strategy designed to optimally slow or stop the bleeding can be followed by the during the operation. patients at risk of significant bleeding after complex cardiac surgery will be approached to allow their operation to be watched by study personnel to see if ongoing blood loss can be accurately measured and to see how quickly a prescribed, standardized blood product replacement protocol to control the bleeding does slow or stop the bleeding. permission to review the medical record to see if bleeding risk features can be identified and permission to follow the patient after surgery to see how they recover is also requested.


Eligibility criteria:
inclusion criteria: eligible male and female patients will include those who are over 18 kg (identified as the lower inclusion threshold so as to standardize cpb circuit dilution) and less than 75 years old (to limit excessive stroke risk) and at theoretically increased risk for excessive bleeding following cardiopulmonary bypass, including patients: 1. undergoing repeat sternotomy, or 2. undergoing combined procedures (i.e. - valve and coronary artery surgery), or 3. undergoing multiple valve surgery, or 4. undergoing aortic root replacement with/without deep hypothermic circulatory arrest, or 5. undergoing complex congenital cardiac surgery exclusion criteria: ineligible patients include those: 1. with known coagulation factor deficiency, or 2. refusing to receive donor blood products if necessary, or 3. undergoing emergency surgery, or 4. undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or 5. with history of previous stroke or other significant thromboembolic event within 6 months (such as pulmonary embolism, valve obstruction \[if not replacing this valve in upcoming operation\], renal vein thrombosis, acute mi, dvt ), or 6. with known thrombophilia, or 7. with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia) 8. pregnant, or 9. weight \> 150 kg or \< 18 kg

Keywords: hemorrhage cardiopulmonary bypass blood component transfusion hemostasis, surgical
short and long-term results of skin versus skin plus orbicularis resection blepharoplasty

Conditions: Dermatochalasis of Eyelid; Ocular Surface Disease; Meibomian Gland Dysfunction; Dry Eye; Brow Ptosis

Summary: this study aims to evaluate the short and long-term effects of skin-only and skin+muscle excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow position.

the study was designed with the approval of the ethics committee on human research of marmara university and was conducted following the tenets of the declaration of helsinki. written informed consent was obtained from all patients who received information about the procedure and the postoperative course. the study included 48 eyes of 24 patients older than 18 who applied to marmara university oculoplastic and orbital surgery unit due to dermatochalasis and were suggested upper eyelid blepharoplasty for medical or cosmetic purposes. the patients were divided into two groups, group s (n=12) for skin excision only and group m (n=12) for skin+muscle excision by the decision of the surgeon. in addition to all ophthalmological examinations, sub-basal nerve plexus parameters with corneal confocal microscopy, schirmer i test, non-invasive tear break-up time, meibomian gland area loss measurements with infrared meibography, central eyebrow height, and lateral eyebrow height were evaluated at baseline and postoperative 1st week, 1st month and 1st-year follow-ups.

Eligibility criteria:
inclusion criteria: * patients older than 18. * patients with dermatochalasis. * patients who were suggested upper eyelid blepharoplasty for medical or cosmetic purposes. exclusion criteria: * patients who have had previous periorbital or ophthalmic surgery * patients with extensive blepharitis * history of contact lens use * history of ophthalmic, endocrinological, neurological, or rheumatological diseases * history of facial paralysis * negative bell's phenomenon * schirmer test \<5mm * the patients who had been treated with periocular botulinum toxin in the last 1 year were not included the study.

Keywords: blepharoplasty skin orbicularis oculi corneal confocal microscopy meibomian gland dry eye eyebrow
dietary supplements to treat radiation-induced rectal injury

Conditions: Radiotherapy; Radiation Proctitis

Summary: this clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (tb) as dietary supplements in the treatment of chronic radiation-induced rectal injury (rri). we hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. the study will test whether the supplements can lower the lent-soma scales of rectal bleeding and enhance overall patient health. efficacy will be evaluated through blood tests and other non-invasive methods, ensuring patient safety and comfort throughout the study.


Eligibility criteria:
inclusion criteria: * age 18-75 years * at least 3 months since the completion of pelvic radiotherapy * no evidence of tumor recurrence or metastasis * rectal bleeding with grade 1-2 by lent-soma scales exclusion criteria: * acute or chronic infectious diseases * serious systemic diseases * known allergies to any components of the study medication * colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis * late complications related to pelvic radiation injury * other hemorrhagic or coagulation disorders * previous rectal resection * bowel obstruction or perforation that require surgery * cognitive or psychological disorder

Keywords: radiotherapy radiation proctitis tributyrin rectal bleeding butyrate
scintigraphy study to compare the antireflux activity of the z0063 versus gaviscon double action tablets, in healthy adult subjects

Conditions: Gastroesophageal Reflux Disease

Summary: primary objective: pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of alginate rafts (raft performance) of z0063 to the effect of gaviscon double action tablets, in healthy adult subjects. secondary objective: safety: assessment of the clinical safety of z0063 versus gaviscon double action tablets, in healthy adult subjects.

the total study duration per subject is 37 days including a screening period up to 21 days, a wash-out period of 4-7 days and a follow-up of 4-7 days.

Eligibility criteria:
inclusion criteria : * male or female subjects, between 18 and 55 years of age, inclusive. * body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 28.0 kg/m\^2, inclusive. * certified as healthy by a comprehensive clinical assessment. * normal vital signs, electrocardiogram (ecg) and laboratory parameters. * subject has to be willing to eat the standard radiolabelled meal (eggs on toasts and orange juice). exclusion criteria: * any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation. * blood donation of more than 450 ml within 3 months before inclusion. * history or presence of drug or alcohol abuse. * smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. * if female, pregnancy (defined as positive beta-human chorionic gonadotropin \[β-hcg\] blood test), breast-feeding. * any medication (including st john's wort) within 14 days before inclusion with the exception of hormonal contraception or menopausal hormone replacement therapy. * any subject in the exclusion period of a previous study: participation in a new chemical entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days. * any subject who cannot be contacted in case of emergency. * positive result on any of the following tests: hepatitis b surface (hbs ag) antigen, anti-hepatitis c virus (anti-hcv) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-hiv1 and anti hiv2 ab). * positive result on urine drug screen. * positive alcohol test. * known hypersensitive to alginates, products or formulation excipients and/or to any component of the standardized meal. * any subject with difficulty in chewing and/or swallowing. * participation in a study in which radioisotopes were administered or in which subject was exposed to any radiation other than normal background radiation within the 12 months before the screening visit. * any intake of aluminum and magnesium containing antacids or other alginate-containing medicinal products within 14 days before inclusion. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
methods of early detection and grading of diabetic peripheral neuropathy (medon)

Conditions: Neuropathy, Diabetic; Neuropathy, Painful

Summary: medon aims to examine new methods for early detection and grading of diabetic peripheral neuropathy focusing on both small- and large nerve fibers. furthermore, medon aims to describe differences between people with classic diabetic peripheral neuropathy and those with painful diabetic neuropathy.


Eligibility criteria:
inclusion criteria: 1. men and women minimum 18 years of age and maximum 75 years of age 2. signed informed consent form 3. diagnosed with diabetes type i (for group 1-3) 4. diagnosed with dpn defined as a threshold above 25-volt biothesiometry or absent feeling on the big toe using 10g-monofilament. (for group 1-2) 5. answered questionnaire: paindetect 6. nothing abnormal on initial tests (group 4) 7. accepted initial screening blood samples 8. mri-compatible participant exclusion criteria: * 1. current or previous alcohol- or drug abuse 2. abnormal screening blood samples 3. not being able to understand danish written and/or verbally 4. not being able to corporate to examination (e.g. not being able to speak, suffering from senile dementia etc.) 5. previous chemotherapy or intake of experimental medicine 6. active hsv- or vzv-infection or known hiv 7. known severe skin disease 8. known neural damage or disease in the neural system (e.g. ms, guillain-barre etc.) 9. critical limb ischemia defined as in current clinical consensus 10. allergy or intolerance to histamine or inability to make do without for one day 11. pregnancy 12. active cancer-disease

Keywords: diabetes neuropathy early detection small nerve fibers
study of sgn-40 in patients with relapsed diffuse large b-cell lymphoma

Conditions: Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Summary: this is a phase ii, open-label, multidose trial of sgn-40 designed to estimate objective response rate and assess toxicity in patients with relapsed dlbcl.


Eligibility criteria:
inclusion criteria: * diagnosis of dlbcl. * received at least one combination chemotherapy regimen with rituximab, such as r-chop, r-eshap or equivalent. * progression or relapse since most recent therapy. * at least one measurable lesion that is both greater than or equal to 2 cm by conventional ct or greater than or equal to 1.5 cm by spiral ct. exclusion criteria: * previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma. * primary refractory disease. * received an allogenic stem cell transplant.

Keywords: antigens, cd40 antibody, monoclonal lymphoma, large b-cell, diffuse lymphoma, non-hodgkin hematologic diseases immunoproliferative disorders lymphatic diseases lymphoproliferative disorders lymphoma
endothelial dysfunction and plaque vulnerability

Conditions: Acute Coronary Syndrome

Summary: thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability. the high resolution of optical coherence tomography (oct) provides an accurate measurement of fibrous cap thickness. endothelial dysfunction is a key component of vulnerable plaque and digital reactive hyperemia-peripheral arterial tonometry (rh-pat) is a non-invasive automatic and quantitative method to evaluate endothelial function. the investigators will investigate the association between endothelial function assessed by rh-pat and plaque vulnerability determined by oct-derived thin-cap fibroatheroma (tcfa).

consecutive patients with acute coronary syndrome (acs) who undergo both oct examination and rh-pat examination are enrolled. oct examination is performed to observe the culprit lesion before percutaneous coronary intervention, and endothelial function is evaluated using rh-pat before discharge.

Eligibility criteria:
inclusion criteria: * patients with angiographically proven acs (luminal stenosis of at least 50%) who undergo both oct examination before coronary stent implantation and rh-pat examination before discharge. exclusion criteria: * none

Keywords: coronary artery disease endothelial function optical coherence tomography thin cap fibroatheroma
efficacy of chf1535 via next dpi versus pmdi and bdp dpi100µg on peakexpiratoryflow in asthmatic patients

Conditions: Asthma

Summary: the purpose of this study is to demonstrate that chf 1535 next dpi® is non-inferior to the corresponding dose of chf 1535 pmdi and superior to marketed beclomethasone dpi 100 µg in terms of average pre-dose morning peak expiratory flow (pef) in asthmatic adult patients.

the primary objective is to demonstrate that chf 1535 next dpi® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of chf 1535 pmdi in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning pef) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid.

Eligibility criteria:
inclusion criteria: 1. male and female adults (≥18 years old). 2. reversibility test defined as δfev1 ≥ 12% and ≥ 200 ml . 3. fev1 \> 80% of the predicted values . 4. asthma control questionnaire score \< 1.25. 5. asthmatic patients 6. non- or ex-smokers exclusion criteria: 1. history of near fatal asthma. 2. copd patients 3. asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period. 4. lower respiratory tract infection within 1 month prior visit1 (v1). 5. history of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency. 6. diagnosis of restrictive lung disease. 7. patients treated with oral or parenteral corticosteroids in the previous 2 months before v1 8. intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments. 9. significant medical history of and/or treatments 10. active cancer or a history of cancer .
a trial to learn more about repeated monthly injections of lu ag09222 in participants with allergies to grass pollen

Conditions: Allergic Rhinitis

Summary: the main goal of this trial is to learn more about the safety of repeated dosing with lu ag09222. the trial doctors will keep track of the participant's overall health by asking them how they are and by analyzing blood and urine samples.


Eligibility criteria:
inclusion criteria: * the participant has a body mass index (bmi) ≥18.0 and ≤30 kilograms (kg)/square meter (m\^2) at the screening visit. * the participant has a clinical history of grass pollen allergic rhinitis of at least 2 years' duration as diagnosed by a physician. * the participant has a positive specific immunoglobulin e (ige) (defined as ≥class 2, ≥0.70 kilounits \[ku\]/liter \[l\]) against phleum pratense at screening. * the participant has a positive skin prick test with a wheal size ≥3 mm to phleum pratense at screening. * the participant is, in the opinion of the investigator, generally healthy based on medical history (despite the allergic rhinitis), a physical examination, vital signs, an electrocardiogram (ecg), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests. exclusion criteria: * the participant has received sublingual or subcutaneous immunotherapy with phleum pratense within the last 5 years. * the participant is receiving ongoing treatment with any allergy immunotherapy product. * the participant has a clinically relevant history of symptomatic (seasonal or perennial) allergy caused by an allergen source overlapping with the allergen challenge period. * the participant has taken disallowed medication or received a covid-19 vaccination within the protocol-specified amount of time before day 1. * the participant has a relevant history of systemic allergic reaction, for example anaphylaxis with cardiorespiratory symptoms, generalized urticaria, or severe facial angioedema, which in the opinion of the investigator may constitute an increased safety concern. other inclusion and exclusion criteria may apply.
rapid hepatitis c elimination trial- a pilot study of daclatasvir/asunaprevir/bms-791325 with or without ribavirin to treat hepatitis c virus

Conditions: Hepatitis C

Summary: the purpose of this study is to determine whether treatment with daclatasvir/asunaprevir/bms-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis c in patients without cirrhosis.


Eligibility criteria:
inclusion criteria: * subjects chronically infected with hcv genotype 1a * hcv rna ≥ 10,000 iu/ml at screening * treatment-naïve subjects with no previous exposure to an interferon formulation (ie, ifnα, pegifnα), ribavirin (rbv), or hcv direct acting antiviral (daa; protease, polymerase inhibitor, etc.) exclusion criteria: * evidence of cirrhosis * liver or any other organ transplant * current or known history of cancer within 5 years prior to enrollment * documented or suspected hepatocellular carcinoma (hcc) * not eligible for sofosbuvir + pegylated interferon + ribavirin therapy

Keywords: hepatitis hepatitis, chronic hepatitis c hepatitis c, chronic liver diseases digestive system diseases hepatitis, viral, human rna virus infections antiviral agents drug resistance, viral
a randomized double blind, placebo controlled balanced 4-way crossover study to assess the efficacy of single oral doses

Conditions: Impotence

Summary: the primary aim of this study is to assess how effective pf-00592379 is in restoring penile erections in patients with erectile dysfunction. patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of pf-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). the effect on penile erections will be assessed in the clinic using penile plethysmography (rigiscan plustm technique).


Eligibility criteria:
inclusion criteria: * erectile dysfunction, previous good response to an oral treatment for erectile dysfunction. exclusion criteria: * patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not. * patients on nitrates or alpha-blocker medications.
contrast-enhanced ultrasound for follow-up after radiofrequency ablation of kidney lesions

Conditions: Carcinoma, Renal Cell

Summary: radiofrequency ablation (rfa) is an increasingly popular therapy option for treating small kidney cancer, especially for patients who are not ideal candidates for traditional surgery. currently, follow-up after this procedure involves the patient having several ct scans (or mri scans in some cases) over time to monitor for possible cancer recurrence. however, there are risks associated with the radiation exposure from ct scans and other risks, such as adverse events from the contrast media used in these scans. this study will therefore investigate whether a different technique, contrast-enhanced ultrasound (ceus), can be an effective tool for follow-up monitoring of kidney cancer patients who have undergone rfa by comparing the results of their standard follow-up ct scans (or mris if applicable) with the results of ceus. if ceus is found to be just as effective as ct scans or mris in detecting kidney cancer recurrence, this technique could potentially become the new standard of care for follow-up.


Eligibility criteria:
inclusion criteria: * at least 18 years of age and capable of giving informed consent * patient undergoing ct of mri for monitoring of renal lesions after radiofrequency ablation exclusion criteria: * pregnant patients * patients with allergies to iodinated contrast agents * patients with pulmonary hypertension, right-to-left cardiac shunts, or unstable cardiopulmonary disease (these are absolute or relative contraindications to the use of the ultrasound contrast agent, perflutren lipid microsphere)

Keywords: renal cell carcinoma radiofrequency ablation contrast enhanced ultrasound monitoring follow up
the use of corticotomy for upper incisors retraction

Conditions: Class II Division 1 Malocclusion

Summary: we aim to assess the treatment outcomes following upper incisors retraction accelerated by corticotomy procedure. so, we intend to randomize orthodontic patients with class ii division i malocclusion into two groups: experimental group and control group. both groups will start orthodontic treatment. once a 0.019\*0.025-inch stainless steel wire is fully engaged to the brackets, 1st premolars will be extracted. canines will be retracted in the conventional manner. then, the actual evaluation period starts when the upper incisors are retracted using two different methods.

in the last three decades, the number of adult patients seeking short orthodontic treatment time has apparently increased as the conventional orthodontic treatment usually lasts for 20-24 months. furthermore, orthodontic treatment is often associated with root resorption, bone degradation and caries development. patients nowadays desire to end the orthodontic treatment as soon as possible due to phsycosocial reasons and to get the goals of the treatment without affecting their social life . so many tooth movement accelerating methods have been proposed. however, the surgical approached are considered the most effective and promising methods in accelerating tooth movement. the current research aims to evaluate the efficacy of the a new proposed surgical method compared to the conventional method in upper incisors' retraction.

Eligibility criteria:
inclusion criteria: * adult patients 15 to 27 years , with permanent dentition , without hypodontia . * overjet less than 10 mm * normal or increased growth pattern (diagnosed by y-axis angle) * mild to moderate crowding (less than 3 mm) * after canines retraction , at least 3 mm space should be available distal the lateral incisors * midline deviation shouldn't be more than 3 mm exclusion criteria: * medically contraindicated patients to oral surgery . * existence of general health issue that affect orthodontic teeth movement * previous orthodontic treatment * mixed dentition * hypodontia (except third molars) * bad oral hygiene